EN    EN EN EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2009) XXX final D004865/01 
  
Draft 
COMMISSION DIRECTIVE .../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
flocoumafen as an active substance in Annex I thereto 
EN EN 2   EN Draft 
COMMISSION DIRECTIVE .../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
flocoumafen as an active substance in Annex I thereto 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 
16 February 1998 concerning the placing of  biocidal products on the market1, and in 
particular the second subparagraph of Article 16(2) thereof, 
Whereas: (1) Commission Regulation (EC)  No 1451/2007 of 4 December 2007 on the second phase 
of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of 
the European Parliament and of the Counc il concerning the pl acing of biocidal 
products on the market 
2 establishes a list of active substances to be assessed, with a 
view to their possible inclusion in Annex I, IA or IB to Directiv e 98/8/EC. That list 
includes flocoumafen. 
(2) Pursuant to Regulation (EC) No 1451/2007, flocoumafen has been evaluated in 
accordance with Article 11(2)  of Directive 98/8/EC for use in product-type 14, 
rodenticides, as defined in Annex V to Directive 98/8/EC. 
(3) The Netherlands was designated as Rapporteur Member State and submitted the 
competent authority report, together w ith a recommendation, to the Commission on 4 
October 2007 in accordance with Article 14(4) and (6) of Regulation (EC) No 
1451/2007. 
(4) The competent authority report was re viewed by the Member States and the 
Commission. In accordance with Article 15 (4) of Regulation (EC) No 1451/2007, the 
findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on 15 May 2009, in an assessment report. 
(5) It appears from the examinations made that biocidal products used as rodenticides and 
containing flocoumafen may be expected not to present a risk to humans except for 
                                                 
1 OJ L 123, 24.4.1998, p. 1. 
2 OJ L 325, 11.12.2007, p. 3. EN 3   EN accidental incidents with children. A risk has been identified regarding non-target 
animals. However, flocoumafen is for the ti me being considered essential for reasons 
of public health and hygiene. It  is therefore justified to include flocoumafen in Annex 
I, in order to ensure that in all Member St ates authorisations for biocidal products used 
as rodenticides and containi ng flocoumafen can be granted,  modified, or cancelled in 
accordance with Article 16(3)  of Directive 98/8/EC. 
(6) In the light of the findings of the assessmen t report, it is appropriate to require that 
specific risk mitigation measures are applie d at product authorisation level to products 
containing flocoumafen and used as rodentic ides. Such measures should be aimed at 
limiting the risk of primary and secondary exposure of humans and non-target animals 
as well as the long term effects of the s ubstance on the environment. To this end, 
certain constraints such as the maximum concentration, the prohibition on marketing 
the active substance in products  which are not ready to use and the use of aversive 
agents should be imposed across the boar d, while other conditions should be imposed 
by the Member States on a case by case basis. 
(7) In view of the identified risks and its ch aracteristics, which render it potentially 
persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, flocoumafen should be incl uded in Annex I for five years only and 
should be made subject to a comparative risk assessme nt in accord ance with the 
second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in 
Annex I is renewed. 
(8) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance flocoumafen an d also to facilitate the proper operation 
of the biocidal products market in general. 
(9) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
have prepared dossiers can benefit fully fr om the 10-year period of data protection, 
which, in accordance with Artic le 12(1)(c)(ii) of Directive 98/8/EC, starts from the 
date of inclusion. 
(10) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC, and in  particular, to grant, modify or cancel 
authorisations of biocidal  products in product-type 14 containing flocoumafen to 
ensure that they comply with Directive 98/8/EC. 
(11) Directive 98/8/EC should therefore be amended accordingly. 
(12) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 98/8/EC is amended in a ccordance with the Annex to this Directive. EN 4   EN Article 2  
1. Member States shall adopt and publish, by 30 September 2010 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive. 
They shall apply those pr ovisions from 1 October 2011. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 Stavros DIMAS  Member of the Commission  
EN 5   EN ANNEX  
The following entry ‘No. 31’ is insert ed in Annex I to Directive 98/8/EC:  
 
No Common 
Name  IUPAC Name 
Identification Numbers Minimum 
purity of the 
active substance 
in the biocidal product as 
placed on the 
market Date of 
inclusion Deadline for compliance with Article 16(3) 
(except for products containing more than one 
active substance, for which the deadline to 
comply with Article 16(3) shall be the one set 
out in the last of the inclusion decisions relating to its active substances) Expiry date of 
inclusion Product 
type Specific provisions (*) 
"31 Flocoumafen 4-hydroxy-3-
[(1RS,3RS;1RS,3RS)-1,2,3,4-
tetrahydro-3-[4-(4-
trifluoromethylbenzyloxy)phenyl]-1-naphthyl]coumarin 
EC No: 421-960-0 
CAS No: 90035-08-8 955 g/kg 1 October 
2011 30 September 2013 30 September 
2016 14 In view of the fact that the active substance chara
c
render it potentially persistent, liable to bioaccumu l
toxic, or very persistent and very liable to bioaccumu
active substance is to be subject to a comparat i
assessment in accordance with the second subpara g
Article 10(5)(i) of Directive 98/8/EC before its incl u
this Annex is renewed.  
Member States shall ensure that authorisations are s u
the following conditions: (1) The nominal concentration of the active subs
t
products shall not exceed 50 mg/kg and only r e
use products shall be authorised. 
(2) Products shall contain an aversive agent and ,
appropriate, a dye. 
(3) Products shall not be used as tracking powder. 
(4) Primary as well as secondary exposure of huma n
target animals and the environment are minim i
considering and applying all appropriate and a
risk mitigation measures. Those include, amongs t
the restriction to professional use only, setting a
limit to the package size and laying down oblig a
use tamper resistant and secured bait boxes." 
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are availabl e on the Commission website: http://ec.europa.eu/comm/envir onment/biocides/index.htm